Systems, devices and methods for lymph specimen tracking, drainage determination, visualization and treatment

ABSTRACT

Disclosed are systems and methods of lymphatic specimen tracking, visualization, and lymph node drainage pathway determination. An exemplary method includes receiving computed tomographic (CT) image data corresponding to a CT scan, generating a three-dimensional (3D) model of at least a portion of a patient&#39;s body based on the CT image data, identifying one or more lymph nodes in the 3D model, performing a registration of the 3D model with one or more physical locations in the patient&#39;s body, determining an expected lymph node drainage pathway away from a region of interest through one or more lymph nodes, and displaying the 3D model and the expected lymph node drainage pathway.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S. patentapplication Ser. No. 15/924,888, filed on Mar. 19, 2018, which claimsthe benefit of and priority to U.S. Provisional Application Ser. No.62/508,724, filed on May 19, 2017, the entire contents of each of whichare incorporated herein by reference.

FIELD

The present disclosure relates to systems, devices, and methods forlymph specimen drainage determination, tracking, visualization,treatment, and removal within the lymphatic system.

BACKGROUND

The lymphatic system is part of the circulatory system and is made of anetwork of lymphatic vessels or ducts that are designed to carry lymphto local lymph nodes throughout the body where the fluid is filtered,processed, and sent to the next lymph node down the line until the fluidreaches the thoracic duct or right lymphatic duct where it enters theblood stream. Lymph vessels infiltrate all tissues and organs of thebody. Lymph is generated from capillaries which, because of tissuemotion and hydrostatic pressure, enter the lymph vessels carrying withit local and foreign substances and materials from the tissues. In thisregard, lymph nodes process fluid by sieving and phagocytosis to removeparticulate and cell material delivered by the lymphatic vessels,thereby cleaning it before it is returned to the blood stream.

During procedures involving the treatment and/or removal of tumors andother cancerous tissue located, in particular, in and around the lung,it may be useful to determine the pathways of lymph drainage in order todetermine potential movement of benign or malignant materials as it isfiltered through the lymph nodes. While there are methods for trackingthe pathways of the lymphatic system, there is always a need forimprovement. The present disclosure provides for improved lymphaticspecimen tracking, drainage pathway determination, visualization, andtreatment of lymph nodes.

SUMMARY

Provided in accordance with embodiments of the present disclosure aremethods of lymphatic specimen tracking, visualization, and lymph nodedrainage pathway determination. According to an aspect of the presentdisclosure, an exemplary method includes receiving computed tomographic(CT) image data corresponding to a CT scan, generating athree-dimensional (3D) model of at least a portion of a patient's bodybased on the CT image data, identifying one or more lymph nodes in the3D model, performing a registration of the 3D model with one or morephysical locations in the patient's body, determining an expected lymphnode drainage pathway away from a region of interest through one or morelymph nodes, and displaying the 3D model and the expected lymph nodedrainage pathway.

In another aspect of the present disclosure, identifying one or morelymph nodes in the 3D model includes identifying drainage tiers of theone of more lymph nodes, and the drainage tiers are sentinel nodes, oneor more secondary nodes, and/or one or more tertiary nodes.

In a further aspect of the present disclosure, identifying drainagetiers of the one of more lymph nodes includes color-coding the one ormore lymph nodes based on a drainage tier corresponding to the one ormore lymph nodes.

In another aspect of the present disclosure, the method further includesinjecting the region of interest with a marking agent, sampling the oneof more lymph nodes based on the expected lymph node drainage pathway,and measuring the marking agent within the one or more lymph nodes.

In a further aspect of the present disclosure, the marking agent isselected from the group consisting of an optical coloring agent and aradioactive tracer.

In another aspect of the present disclosure, the method further includesdetermining a measured lymph node drainage pathway away from the regionof interest through the one or more lymph nodes based on the markingagent measured within the one or more lymph nodes, and displaying themeasured lymph node drainage pathway.

In yet another aspect of the present disclosure, the marking agent is aradioactive agent and the displaying of the measured lymph node drainagepathway includes displaying measured emissions of the marking agent.

In still another aspect of the present disclosure, the method furtherincludes generating lymph node information data based the one or morelymph nodes, and the lymph node information data includes one or more ofdrainage tiers, lymph node name, procedure type, patient information,date, marking agent measured, and clinician information.

In a further aspect of the present disclosure, the method furtherincludes outputting the lymph node information data.

In another aspect of the present disclosure, the method further includesnavigating a surgical instrument to the one of more lymph nodes,determining a location of the surgical instrument, analyzing the one ormore lymph nodes at the location of the surgical instrument, andoutputting the lymph node information data for the one or more lymphnodes at the location of the surgical instrument.

Provided in accordance with embodiments of the present disclosure aresystems for lymphatic specimen tracking and visualization. According toan aspect of the present disclosure, an exemplary system includes alaparoscopic camera insertable into a patient and configured to obtainimages, a surgical tool insertable into the patient, a camera sensoroperatively associated with the laparoscopic camera, a tool sensoroperatively associated with the surgical tool, an electromagnetictracking system configured to track the camera sensor and the toolsensor, one or more processors configured to execute instructions which,when executed, cause the one or more processors to receive computedtomographic (CT) image data corresponding to a CT scan, generate athree-dimensional (3D) model of at least a portion of a patient's bodyfrom the CT image data, identify one or more lymph nodes inside the 3Dmodel, perform a registration of the 3D model with one or more physicallocations in the patient's body, and determine an expected lymph nodedrainage pathway away from a region of interest through one or morelymph nodes. The system further includes a display configured to displaya user interface including the 3D model, the expected lymph nodedrainage pathway, and lymph node information data.

In another aspect of the present disclosure, the instructions, whenexecuted, further cause the one or more processors to generate the userinterface, the user interface including a sampling window configured todisplay the identified one or more lymph nodes and the surgical tool asit interacts with the identified one or more lymph nodes inside thepatient's body.

In a further aspect of the present disclosure, the instructions, whenexecuted, further cause the one or more processors to generate the userinterface, the user interface including a measured drainage windowconfigured to display the lymph node drainage pathway and lymph nodeinformation data.

In another aspect of the present disclosure, the instructions, whenexecuted, further cause the one or more processors to generate the userinterface, the user interface including a procedure window configured todisplay and track the surgical procedure being performed.

In yet another aspect of the present disclosure, the instructions, whenexecuted, further cause the one or more processors to receive a previous3D model of at least a portion of the patient's body including previouslymph node information data, and update the 3D model and lymph nodeinformation data based on the previous 3D model and previous lymph nodeinformation data.

In still another aspect of the present disclosure, the instructions,when executed, further cause the one or more processors to generate theuser interface, the user interface including a removal window configuredto display and update the lymph node information data during thesurgical procedure.

In yet another aspect of the present disclosure, the instructions, whenexecuted, further cause the one or more processors to identify drainagetiers of the one of more lymph nodes, wherein the drainage tiers aresentinel nodes and one or more secondary nodes.

In still another aspect of the present disclosure, the lymph nodeinformation data includes one or more of drainage tiers, lymph nodename, patient information, date, and clinician information.

In yet another aspect of the present disclosure, the instructions, whenexecuted, further cause the one or more processors to update the lymphnode information data for the one or more lymph nodes as surgical toolinteracts with the one or more lymph nodes.

In still another aspect of the present disclosure, the instructions,when executed, further cause the one or more processors to generate theuser interface, the user interface including a location windowconfigured to display a portion of the 3D model which corresponds withthe images obtained by the laparoscopic camera.

Any of the above aspects and embodiments of the present disclosure maybe combined without departing from the scope of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects and features of the present disclosure are describedhereinbelow with references to the drawings, wherein:

FIG. 1 illustrates a system suitable for performing laparoscopic surgeryon a patient, in accordance with the present disclosure;

FIG. 2 illustrates a graphical user interface (GUI) utilized fordisplaying a 3D model of a lung including the locations of airways,lymph nodes, and regions of interest, in accordance with the presentdisclosure;

FIG. 3 illustrates a GUI utilized for visualizing lymph node specimensamples and determining accurate lymph node drainage pathways, inaccordance with the present disclosure;

FIG. 4 illustrates a GUI utilized for visualizing lymph node specimensduring a surgical procedure, in accordance with the present disclosure;

FIG. 5 illustrates a exemplary specimen container including a label oflymph node information in accordance with the present disclosure;

FIG. 6 illustrates a method for determining and displaying a lymph nodedrainage pathway in accordance with the present disclosures; and

FIG. 7 illustrates a method for performing lymph node surgicalprocedures and presenting lymph node information data, in accordancewith the present disclosures.

DETAILED DESCRIPTION

The present disclosure is directed to lymphatic specimen tracking,drainage pathway determination, visualization, and treatment of tumorsor other regions of interest within the lymphatic system. Duringtreatment of a tumor or other targets or regions of interest within thelung, it is necessary to ensure that all lymph nodes relevant to atreated or resected tumor are analyzed or removed. In order to determinethat relevant lymph nodes are analyzed and/or removed, to ensure removalof biological material that may have moved throughout the body, it isnecessary to accurately identify the relevant lymph nodes and thedrainage pathways that stem from a tumor or region of interest.

Although this disclosure relates more particularly to the lymphaticsystem of the lungs and surround areas, in some embodiments, the systemsand methods of the present disclosure may be used for various otherforms of surgery, including abdominal surgery, joint surgery, etc.Further details about systems, devices, and methods for obtaining imagedata for and creation of a 3D model are provided in commonly-ownedco-pending U.S. Provisional Patent Application No. 62/315,773, entitled“THORACIC ENDOSCOPE FOR SURFACE SCANNING,” filed on Mar. 31, 2016, bySartor et al., Published as U.S. Patent Application Publication No.2017/0280970, now abandoned, and commonly-owned co-pending U.S.Provisional Patent Application No. 62/369,986, entitled “SYSTEM ANDMETHOD OF USING AN ENDOSCOPIC CATHETER AS A PORT IN LAPAROSCOPICSURGERY,” filed on Aug. 2, 2016, by William S. Krimsky, now U.S. Pat.No. 11,419,490, the entire contents of both of which are incorporatedherein by reference.

The systems, devices, methods, and computer-readable media describedherein are useful for treatment procedures performed on the patient'slungs and surrounding tissue, as well as other areas of the patient'sbody. For example, in an embodiment where a clinician is performingtreatment of an area of the patient's lungs, the methods and systems mayprovide the clinician with various views, including live images from oneor more laparoscopes, one or more views of a 3D model, and one or moremedical images, such as computed tomography (CT) or fluoroscopic images,obtained preoperatively or intra-operatively and selected for displaybased on the tracked location and direction of movement of a surgicaltool used during the procedure. These and other aspects of the presentdisclosure are detailed hereinbelow.

With reference to FIG. 1 , a system 100 suitable for performinglaparoscopic surgery on a patient is provided in accordance with anembodiment of the present disclosure. As shown in FIG. 1 , system 100 isused to perform one or more treatment procedures on a patient supportedon an operating table 40. In this regard, system 100 generally includesat least one laparoscope 30, at least one surgical tool 32, monitoringequipment 60, an electromagnetic (EM) tracking system 70, and acomputing device 80.

Laparoscope 30 includes a source of illumination and a laparoscopiccamera 35 coupled to monitoring equipment 60, for example, a videodisplay, for displaying the video images received from camera 35.Laparoscope 30 is configured for insertion into the patient's body, e.g.through a surgical incision or a laparoscopic port, to provide images ofa surgical site inside the patient's body, for example, inside thepatient's thoracic cavity. As illustrated in FIG. 1 , the patient isshown laying on operating table 40 with laparoscope 30 and surgical tool32 nearby for insertion into the patient's body. Though depicted as anelectrosurgical vessel sealer, surgical tool 32 may be any one of anumber of surgical tools usable during laparoscopic surgery, includingcutting tools, suction tools, single fine-needle aspiration tools,tracer injection tools, radiological detection tools, biopsy tools,resection tools, graspers, ablation tools, ligation tools, surgicalstaplers, ultrasonic and/or electrosurgical vessel sealers, etc.

EM tracking system 70 may be a six degrees-of-freedom EM trackingsystem, e.g., similar to those disclosed in U.S. Pat. No. 6,188,355 andpublished PCT Application Nos. WO 00/10456 and WO 01/67035, entitled“WIRELESS SIX-DEGREE-OF-FREEDOM LOCATOR,” filed on Dec. 14, 1998 byGilboa, the entire contents of each of which are incorporated herein byreference, or any other suitable positioning measuring system, isutilized for performing tracking, although other configurations are alsocontemplated.

EM tracking system 70 may be configured for use with laparoscope 30 totrack the position of EM sensor 94 as it moves in conjunction withlaparoscope 30 about the patient's body, as detailed below. In anembodiment, EM tracking system 70 includes a tracking module 72, aplurality of reference sensors 74, and an EM field generator 76. Asshown in FIG. 1 , EM field generator 76 is positioned beneath thepatient. EM field generator 76 and the plurality of reference sensors 74are interconnected with tracking module 72, which derives the locationof each reference sensor 74 in the six degrees of freedom. One or moreof reference sensors 74 are attached to the patient's chest. The sixdegrees of freedom coordinates of reference sensors 74 are sent as datato computing device 80, which includes an application, where the datafrom sensors 74 are used to calculate a patient coordinate frame ofreference.

As such, laparoscope 30 further includes at least one EM sensor 94. Thelocation of EM sensor 94, and thus the distal end of laparoscope 30,within an EM field generated by EM field generator 76 can be derived bytracking module 72, and computing device 80. Surgical tool 32 may alsoinclude one or more EM sensors 94 to be tracked by tracking module 72similar to laparoscope 30.

Computing device 80 includes various software and/or hardwarecomponents, including one or more applications producing a graphic userinterface for presentation on a display 81 as depicted in FIG. 1 .Computing device 80 may include memory, one or more processors, anetwork interface, an input device, and/or an output module. The memorymay store the applications and/or image data.

The network interface may be configured to connect to a network such asa local area network (LAN) consisting of a wired network and/or awireless network, a wide area network (WAN), a wireless mobile network,a Bluetooth network, and/or the internet. The input device may be anydevice by means of which a user may interact with computing device 80,such as, for example, a mouse, keyboard, foot pedal, touch screen,and/or voice interface. The output module may include any connectivityport or bus, such as, for example, parallel ports, serial ports,universal serial busses (USB), or any other similar connectivity portknown to those skilled in the art.

An application may be employed to facilitate the various phases of thetreatment procedure, including generating the aforementioned 3D model,and navigating laparoscope 30 and/or surgical tool 32 to the treatmentlocation. For example, computing device 80 utilizes CT scan, magneticresonance imaging (MRI) scan, and/or positron emission tomography (PET)scan image data for generating and viewing the 3D model of the patient'sairways. The CT scan generates two-dimensional (2D) slices of thepatient's scanned region, which, for the example of the lungs, mayinclude, among other things, airways, lesions, blood vessels, vascularstructures, lymphatic vessels including lymph nodes, organs, and otherphysiological structures. By combining the slices, the model of thepatient's airway tree, including the above-mentioned structures may, begenerated. While the CT scan image data may have gaps, omissions, and/orother imperfections included in the image data, the 3D model and/ordeflated 3D model is a smooth representation of the patient's airways,with any such gaps, omissions, and/or imperfections in the CT scan imagedata filled in or corrected. By combining all 2D slices, computingdevice 80 is able to generate the smoothed 3D model. The 3D model may bepresented on a display 81 associated with computing device 80, or in anyother suitable fashion.

Using computing device 80, various views of the 3D model may bepresented and may be manipulated by a clinician to give the clinician apreferred view of the treatment location. The 3D model may include,among other things, a model airway tree corresponding to the actualairways of the patient's lungs showing the various passages, branches,and bifurcations of the patient's airway tree. Additionally, the 3Dmodel may include lesions, markers, blood vessels and vascularstructures, lymphatic vessels and structures, organs, otherphysiological structures such as the pleura and fissures of the lungs.Some or all of the aforementioned elements may be selectively displayed,such that the clinician may choose which elements should be displayedwhen viewing the 3D model. The 3D model may also be rotated and zoomedas necessary to achieve a desired view. Further, in accordance aspectsdescribed hereinbelow, a viewing angle may be keyed to a sensed locationof laparoscope 30 and EM sensor 94, such that the view from thelaparoscope can be seamlessly overlaid on the 3D model

After generating the 3D model, a procedure may be undertaken in whichtracking system 70 enables tracking of EM sensor 94 (and thus the distalend of laparoscope 30) as EM sensor 94 is positioned inside thepatient's body. As an initial step of the procedure, the 3D model isregistered with the patient's body. One potential method of registrationinvolves navigating EM sensor 94 about the patient's body to identifyvarious landmarks that may then be used to align the position of thoselandmarks in the 3D model with the position in the patient's body. Theposition of EM sensor 94 is tracked during this registration phase, andthe 3D model is iteratively updated based on the tracked position of EMsensor 94 within the patient's body. Various other registrationprocesses may also be used to register the 3D model with the patient'sbody. Examples of such registration processes are described incommonly-owned U.S. Patent Application Publication No. 2011/0085720,entitled “AUTOMATIC REGISTRATION TECHNIQUE,” filed on May 14, 2010, byBarak et al., the entire contents of which are incorporated herein byreference. While the registration process focuses on aligning thepatient's body with the 3D model, registration also ensures that theposition of airways, vascular structures, pleura, and fissures of thelungs are accurately determined. As will be appreciated, thisregistration enables the depiction of the sensed location of the EMsensor 94 associated with the laparoscope 30 or the surgical tool 32accurately with respect to the 3D model.

Referring now to FIG. 2 , a user interface of the type that would bepresented on display 81 is depicted, including a model window 200. Modelwindow 200 includes a 3D model 215 of a lung and an expected drainagewindow 250. As shown in FIG. 2 , 3D model 215 includes trachea 202, leftlobe 217, containing airways 210, a plurality of lymph nodes 205disposed on or around airways 210, and a region of interest 209. Regionof interest 209 is illustrated as a non-uniform volume, which mayinclude a tumor or other benign or non-benign volume that a cliniciandetermines is important with regard to a laparoscopic procedure.Additionally, 3D model 215 may include lesions, markers, organs, and/orother physiological structures. Some or all of the aforementionedelements may be selectively displayed, such that the clinician maychoose which elements should be displayed when viewing 3D model 215, and3D model 215 may be viewed in various orientations. For example, if theclinician desires to view a particular section of the patient's lungs,the clinician may rotate and/or zoom in on the particular section of thepatient's lungs.

Lymph nodes 205 are illustrated as oval-shaped swellings on airways 110.These may be manually identified by a clinician reviewing the CT imagesfrom which the 3D model is generated. This identification may be done aspart of a CT image viewing stage in an application or alternatively fromreviewing the 3D model itself. Further, there are systems of imageprocessing known in the art through which the lymph nodes can beidentified and depicted in the 3D model. These automatically detectedlymph nodes may be subject to verification by the clinician upon reviewof the 3D model and either accepted or rejected based on the experienceof the clinician.

Although shown in FIG. 2 as single lymph nodes, lymph nodes 205 may beclusters of multiple lymph nodes. Lung lymph nodes are assigned an “R”or an “L” for those lymph nodes located in the right lobe or left lobe,respectively, and are assigned a number based on location. For example,lymph nodes 12L correspond to pulmonary nodes in the lobar region, lymphnodes 11L correspond to pulmonary nodes in the interlobar region, andlymph nodes 10L correspond to pulmonary nodes in the hilar region, andeach assignment may include multiple lymph nodes. As illustrated in FIG.2 , lymph nodes 205 include identifiers as to which of these regionsthey belong (e.g., 14L, 13L, 11L, 10L, 8R, and 4R).

As it relates to a region of interest 209, lymph nodes 205 may beseparated into tiers, such as sentinel or primary lymph nodes, secondarylymph nodes, tertiary lymph nodes, etc. The lymphatic system drains froma sentinel lymph node to secondary lymph nodes to tertiary lymph nodes,etc. Sentinel lymph node are the first lymph nodes to which cancer cellsare most likely to spread from a tumor. Generally, sentinel lymph nodesare those closest to a tumor, and along the expected drainage pathway.The drainage pathway extends next out to secondary nodes followed bytertiary nodes. The determination of which tier each of the plurality ofnodes belongs to is based on, among other characteristics, the locationof lymph nodes 205 with respect to region of interest 209 and thelocation of lymph nodes 205 with respect to the segments of the lung.

With respect to drainage pathways, an expected drainage pathway isdepicted connecting lymph nodes 205 in FIG. 2 , as shown in expecteddrainage window 250. Expected drainage window 250 may be displayed alongwith 3D model 215 within model window 200 or may pop out to be displayedseparately. As shown in FIG. 2 , expected drainage window 250 containsexample lymph node information data 255 for an expected drainage pathwayfrom region of interest 209. This expected drainage pathway may be basedon the location of the region of interest 209, empirical evidence fromprior analyses that is collected digitally and used to generate analgorithm that can predict the interconnectedness of lymph nodes througha combination of image processing, and comparative results collectionand correlation. Alternatively, the expected drainage pathway may bebased on the clinician's experience in conducting prior examination andmay be identified by the clinician when conducting analyses or review ofthe CT images or 3D model. As depicted in FIG. 2 , based on region ofinterest 209, the expected lymph node drainage pathway proceeds fromregion of interest 209 to pulmonary node 11L in the interlobar region(shown as 205(11L)) then to pulmonary node 10L in the hilar region(shown as 205(10L)) and to 5L, an aortic node located near the leftsubaortic valve. Additionally, based on the location of region ofinterest 209, lymph node 205(11L) is the expected sentinel node, lymphnode 205(10L) is the expected secondary drain node, and lymph node205(5L) is the expected tertiary drain node. If, for example, region ofinterest 209 was located in another location, the ordering of lymphnodes 205 may be different. Although only lymph node drainage to a thirdtier is illustrated, additional lymph nodes tiers may also be includedin expected drainage window 250. It should be further noted that thismay be just one drainage pathway to or from region of interest 209, andthat multiple other drainage pathways may also exist for a particularregion of interest and/or sentinel lymph node. Further, here thedrainage pathway appears to be a pathway from regions closer to thetrachea in the direction of the region of interest 209, and there may befurther lymph nodes 205 along this drainage pathway more distal ofregion of interest 209.

In some embodiments, each tier of lymph nodes 205 may be displayed in 3Dmodel 215 as a different color or different shading thereby allowing aclinician to visualize the likely drainage pathway. For example,sentinel nodes may be displayed in red, while secondary nodes aredisplayed in orange, and tertiary nodes are displayed in yellow. In thismanner, a clinician may, by viewing 3D model 215, determine the likelylymph node drainage pathway without additional information. Althoughexpected drainage window 250 details an expected drainage pathway,because each lymph node assignment, such as pulmonary node 11L, mayinclude multiple lymph nodes it is necessary to determine an actual orconfirmed lymph node drainage pathway, as described in the detaileddescription of FIG. 3 .

With reference now to FIG. 3 , sampling window 300 is illustrated. Inaccordance with one aspect of the present disclosure, prior tocollecting tissue samples, which may include biopsying and/or resectinga portion of lymph nodes 205 and/or region of interest 209, the regionof interest 209 may be injected with a radioactive tracking agent(tracer) and/or a marking agent, such as an optical coloring agent or adye, for example, by using surgical tool 32. Once the tracer has beeninjected into region of interest 209, the radiation emission levelsthroughout the lymphatic system in specific lymph nodes may bedetermined by non-invasively sampling likely lymph node drainagepathways. As an example, the clinician may utilize a radiologicalemissions detection tool (32 in FIG. 3 ) to obtain the radiationemission levels from a number of lymph nodes 205. Based on thedifferences in detected emissions, a more accurate lymph node drainagepathway may be determined.

In an alternative or additional aspect of the present disclosure, thelymph node drainage pathway may be determined using a marking agent(e.g., a dye). Once the marking agent has been injected into region ofinterest 209 using a surgical tool 32, tissue sampling (e.g., taking abiopsy of likely lymph nodes) may be undertaken and a determination madewhether a particular sampled lymph node 205 includes the marking agent.If marking agent is found in a particular tissue sample, the drainagepathway can be mapped, thereby determining the lymph node drainagepathway.

Sampling window 300 displays a laparoscopic view 310 including a lymphnode 205 from which a sample can be taken (either tissue or emissions)for determination of a lymph node drainage pathway, in accordance withthe present disclosure. As shown in FIG. 3 , sampling window 300includes a location window 320, which includes a portion of 3D model 215as a modeled representation corresponding to laparoscopic view 310.Location window 320 includes a bounding box 322 that serves to displaythe laparoscopic view 310 overlaid onto the 3D model. As can be readilyappreciated, this provides greater context for the clinician whenconsidering the laparoscopic view 310. Laparoscopic view 310 includes areal-time image of lymph node 205, tissue 315, and surgical tool 32,which is obtained by laparoscopic camera 35. In one embodiment, as aclinician manipulates the location of laparoscope 30 and the displayshown in laparoscopic view 310 changes, the corresponding locationwithin location window 320 and bounding box 322 changes the portion ofthe 3D model 215 which is depicted to ensure that the image within thebounding box 322 is presented properly in context with the 3D model. Asnoted above, a clinician may manually mark specific lymph nodes 205.This may be as a result of laparoscopic imaging via laparoscopic camera35 providing greater clarity for uncovering lymph nodes 205 not seen inthe models. In some embodiments, manual identification is the onlymechanism available to identify a location of a lymph node 205 on the 3Dmodel 215, and thus be represented in the images displayed in locationwindow 320. The coordination between laparoscopic view 310 and locationwindow 320 is due to the previous registration of 3D model 215 with thepatient, which serves to align the laparoscopic images with the 3Dmodel, so that locations of 3D model 215 corresponding to similarlocations within the patient's airways within the EM field areconsistently displayed. Thus, based on the location of laparoscope 30,which is trackable, the locations within 3D model 215 may be determinedand updated, and data from 3D model 215, such as lymph node locationscan be depicted in corresponding relationship with the laparoscopic view310.

Further included within sampling window 300, is measured drainage window350. Measured drainage window 350 includes lymph nodes information data255 and is utilized to display a specific drainage pathway from regionof interest 209, based on, for example, a tracking agent and/or amarking substance injected into region of interest 209. In the exampledepicted in measured drainage window 350 of FIG. 3 , region of interest209, previously injected with a tracer and was measured as having aradiation emission level of 0.75 millicurie (mCi). A 12L lymph node 205was measured at 0.57 mCi, an 11L lymph node 205 was measured at 0.42mCi, and a 10L lymph node 205 was measured at 0.28 mCi. Thus, fromregion of interest 209, the lymph node drainage pathway progresses fromthe 12L lymph node (sentinel node), through the 11L lymph node(secondary drain node), and to the 10L lymph node (tertiary drain node.)

Because each lymph node region (14L, 13L, 10L, etc.) contains multiplelymph nodes, each lymph node within a specific assignment may not drainfrom or to region of interest 209. By utilizing an emission detectionprocess described herein, a more specific lymph node drainage pathwaymay be determined. This data can be incorporated into the 3D model datato effectively redraw the drainage pathway in instances where theexpected drainage pathway proved inaccurate or incomplete.

As described in the detail description of FIG. 1 , the physical locationof surgical tool 32 may be tracked using EM sensors 94. Additionally,because 3D model 215 is registered with the patient's body, a clinicianis able to confirm that the locations of lymph nodes 205, which areshown in 3D model 215, correspond with the physical location of EMsensor 94 of surgical tool 32. This assists to properly define thelocations of the lymph nodes 205 for biopsy, resection, and/or analysis.As the clinician samples lymph nodes 205, based on the physicallocations of surgical tool 32, measured drainage window 350 is updatedwith lymph node information data 255. Lymph node information data 255may include the lymph node assignment and level of radiation levels orpresence of marking agent. As a clinician continues to sample lymphnodes 205, 3D model 215 and location window 320 is continually updatedto indicate the sampling of lymph nodes and measured drainage window 350is continually updated to include additional lymph node information data255, such as classification tier, lymph node assignment (12L, 10L, etc.)and radiation emission levels.

Referring now to FIG. 4 , procedure window 400 is illustrated. Procedurewindow 400 is utilized in order to track, in real-time, resection and/orbiopsy of lymph nodes 205 and/or region of interest 209. As shown inFIG. 4 , procedure window 400 includes location window 320 andlaparoscopic view 310. Similar to FIG. 3 , location window 320 includesbounding box 322 that corresponds to the location within 3D model 215that in turn corresponds to the location and images shown inlaparoscopic view 310. Laparoscopic view 310 includes a display ofsurgical tool 32, lymph nodes 205, and tissue 315 and allows a clinicianto see surgical tool 32 as it interacts with regions with the patient'sbody. As illustrated in FIG. 4 , surgical tool 32 is shown as a biopsytool in physical contact with lymph node 205.

Further included within procedure window 400 is removal window 450.Removal window 450 is utilized to determine which lymph nodes 205 and/orregion of interest 209 have been biopsied and/or removed to provide aclinician with pertinent information regarding the lymph nodes 205and/or region of interest 209. As the clinician biopsies and/or resectslymph nodes 205 and/or region of interest 209, based on the physicallocations of EM sensor 94 of surgical tool 32, removal window 450 isupdated with lymph node information data 255, which may include thelymph node assignment, lymph node specimen number, removal date,clinician name, and type of procedure performed on lymph node 205 andregion of interest 209. For example, where a 12L lymph node 205 isremoved, analyzed, or biopsied only, removal window 450 may be updatedto include this information. During a procedure, as a cliniciancontinues to biopsy, resect, and/or analyze lymph nodes 105, removalwindow 450 is continually updated. In addition, where the currentprocedure continues from a previous procedure, 3D model 215 from theprevious procedure may be imported thereby updating the current 3D model215 and importing within removal window 450 past dates, clinicians, andlymph nodes 205, which have already been analyzed or removed. Thus,procedure window 400 and removal window 450 allow a clinician to ensurethat the correct lymph nodes are being removed and/or analyzed andensures that previously removed and/or analyzed lymph nodes are handledappropriately.

Referring now to FIG. 5 , an illustration of a specimen container 500containing a label 505, which includes lymph node information data 255and barcode 520. Where necessary, a clinician is able to utilizeinformation from measured drainage window 350 and removal window 450 andgenerate a printout of label 505 including lymph node information data255. Label 505 may then be affixed to specimen container 500 therebyallowing the clinician to gain, among other benefits: (1) minimizedlabeling errors; and (2) confidence that the procedures performed oneach lymph node 205 is known, as each label 505 will correspond to asingle lymph node and include lymph node information data 255.

Referring now to FIG. 6 , a flowchart illustrating a method 600 fordetermining and displaying a lymph node drainage pathway is shown inaccordance with the present disclosure. Method 600 details steps takenprior to the removal of region of interest 209 and details bothradiological and biopsy sampling. Generally, during the removal of lymphnodes 205, sentinel and possibly secondary lymph nodes 205 are removed.However, it is necessary to determine the locations of tertiary nodesfor potential subsequent surgical procedures and confirmation ofcompletion of removal. Method 600 begins at step 605 where patient CTimage data is received and 3D model 215 is generated. As furtherdescribed in the detailed description of FIG. 1 , using CT images of thepatient's airways, a 3D model, such as 3D model 215, may be generatedfrom CT images using computing device 80. Next, at step 610, thelocations within 3D model 215 are registered to corresponding physicallocations of the patient's body.

Next, at step 615, one or more lymph nodes 205 and/or a region ofinterest 209 are identified within 3D model 215. The lymph nodeassignments (14L, 10L, 5L, etc.) are also identified within 3D model215. Lymph nodes 205 and/or region of interest 209 are identified asdescribed above from the CT images of the patient or the 3D model 215.Next, at step 620, based on the location of region of interest 209,expected drainage window 250 may be generated. As described in thedetailed description of FIG. 2 , lymph nodes 205 may be colored orshaded to allow a clinician to better determine where in 3D model 215and the patient's body lymph nodes 205 are located. Next, at step 625,3D model 215 is displayed along with the expected lymph node drainagepathway. Next, at step 630, region of interest 209 is injected with amarking agent, such as a tracer.

At step 635, a sample of lymph nodes 205 around region of interest 209may be taken in order to determine lymph node drainage pathways, asdescribed further in the detailed description of FIG. 3 . Next, at step640, a determination is made of whether all necessary lymph nodes havebeen sampled. If it is determined that all necessary lymph nodes 205have been sampled, method 600 proceeds to step 645. If it determined, atstep 640, that all necessary lymph nodes 205 have not been sampledmethod 600 returns to step 635.

At step 645, an updated lymph node drainage pathway is determined basedon the sampling. Next, at step 650, the lymph node drainage pathway isupdated and generated based on the samples and is displayed in measureddrainage window 350. In some embodiments, each of lymph nodes 205displayed within 3D model 215 as updated have different colors orshadings based on the lymph nodes drainage tier (sentinel, secondary,tertiary, etc.)

Turning now to FIG. 7 , a flowchart illustrating an exemplary method 700for performing lymph node surgical procedures and presenting lymph nodeinformation data 255 is shown, in accordance with the presentdisclosure. Method 700 details steps taken during removal of all or aportion of region of interest 209 and lymph nodes 205 and confirmationthat accurate and correct lymph nodes 205 were removed. Method 700begins at step 705 where a clinician selects a 3D model 215 includingregion of interest 209 or lymph node 205 for which a surgical procedureis to be performed. Next, at step 707, the selected 3D model isregistered with the patient. Thereafter, at step 710, the clinicianperforms a laparoscopic procedure and moves surgical tool 32 andlaparoscope 30 to region of interest 209 or lymph node 205, as furtherdescribed in the detailed description of FIG. 1 . As surgical tool 32 ismoved to the physical location of lymph nodes 205 and/or region ofinterest 209, the location of EM sensor 94 of surgical tool 32 istracked at step 715. Next, at step 720, using the physical location oflaparoscope 30, laparoscopic view 310 changes. Location window 320including images generated from 3D model 215 changes based on thephysical location of EM sensor 94 of laparoscope 30 due to theregistration between 3D model 215 and the patient and detection of EMsensor 94 in the EM field. Additionally, based on the location of EMsensor 94 of surgical tool 32 and or laparoscope camera 30, current andprevious lymph node information data 255 of those lymph nodes 205 may beobtained. For example, where lymph nodes 205 have been previouslybiopsied, previous lymph node information data 255 may be obtained fromcomputing device 80 and displayed.

Next, at step 725, a clinician may perform a biopsy, resection, and/orother surgical procedure with respect to lymph nodes 205 and/or regionof interest 209. Next, at step 730, computing device 80 generates thelymph node information data 255, which may include a patientidentification, lymph node name, specimen number, clinician name,procedure type, date of procedure, estimated volume of the target lymphnode from preoperative imaging, relative mapping radiation, and/or imageagent intensity. At step 735, lymph node information data 255 isdisplayed and continually updated via removal window 450 as surgicalprocedures are performed on lymph nodes 205 and/or region of interest209, as further described in the detailed description of FIG. 4 .Additionally, where necessary, the clinician has the option, at step735, of outputting the lymph node information data 255 via a printout ora label such as label 510 of FIG. 5 . Conversely, the information may beassociated with a pre-labeled sample file, the pre-labeled file ID beingscanned in coordination with placing the sample in the sample file.

Next, method 700 proceeds to step 740 where it is determined whetherthere are additional lymph nodes 205 and/or region of interest 209 whichrequire a surgical procedure. If, at step 740, it is determined that noadditional surgical procedures are required, method 700 ends. If, atstep 740, it is determined that additional lymph nodes 205 and/or regionof interest 209 require a procedure, method 700 returns to step 710,where surgical tool 32 and laparoscope camera 30 are navigated toanother lymph node 205 or region of interest 209.

With specific reference to the methods described herein, thoughdescribed in a particular order, the present disclosure is not intendedto be so limited. For example, the registration step described withreference to both FIGS. 6 and 7 may occur at alternative times withinthe flow of the methods described without departing from the scope ofthe present disclosure. Further, the methods described here may beexpressed in one or more applications, as described above, to produceone or more graphic user interfaces for presentation on a display inorder to achieve the described methodology.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of particular embodiments. Those skilled in the artwill envision other modifications within the scope and spirit of theclaims appended hereto.

1-20. (canceled)
 21. A method of lymphatic specimen tracking,visualization, and lymph node drainage pathway determination, the methodcomprising: generating a three-dimensional (3D) model of at least aportion of a patient's body; identifying two or more lymph nodes in the3D model; identifying a drainage tier of each of the two or more lymphnodes, the drainage tier including one of sentinel nodes, one or moresecondary nodes, or one or more tertiary nodes; measuring radiationemission levels from the one or more lymph nodes; and displaying a lymphnode data user interface including: an image of a first lymph node ofthe two or more lymph nodes and first lymph node information dataincluding the radiation emission levels measured for the first lymphnode; and an image of a second lymph node of the two or more lymph nodesand second lymph node information data including the radiation emissionlevels measured for the second lymph node, wherein the image of thefirst lymph node is displayed in a first configuration based on theidentified drainage tier of the first lymph node and wherein the imageof the second lymph node is displayed in a second configurationdifferent from the first configuration based on the identified drainagetier of the second lymph node.
 22. The method according to claim 21,further comprising: injecting a region of interest with a marking agent;sampling at least one of the two of more lymph nodes based on anexpected lymph node drainage pathway; and measuring the marking agentwithin the sampled lymph node.
 23. The method according to claim 22,wherein the marking agent is selected from the group consisting of anoptical coloring agent and a radioactive tracer.
 24. The methodaccording to claim 22, further comprising: determining a measured lymphnode drainage pathway away from the region of interest through at leastone of the two or more lymph nodes based on the marking agent measuredwithin the sampled lymph node; and displaying the measured lymph nodedrainage pathway.
 25. The method according to claim 24, wherein themarking agent is a radioactive agent and the displaying of the measuredlymph node drainage pathway includes: displaying measured emissions ofthe marking agent.
 26. The method according to claim 22, wherein thelymph node data user interface includes one or more of a lymph nodename, procedure type, patient information, date, marking agent measured,or clinician information.
 27. The method according to claim 21, whereinthe image of the first lymph node is displayed in a first color based onthe identified drainage tier of the first lymph node and wherein theimage of the second lymph node is displayed in a second color differentfrom the first color based on the identified drainage tier of the secondlymph node.
 28. The method according to claim 21, further comprising:determining an expected lymph node drainage pathway away from a regionof interest through at least one of the one or more lymph nodes; anddisplaying the 3D model and the expected lymph node drainage pathway.29. A system for lymphatic specimen tracking and visualization, thesystem comprising: one or more processors configured to executeinstructions which, when executed, cause the one or more processors to:generate a three-dimensional (3D) model of at least a portion of apatient's body; identify two or more lymph nodes inside the 3D model;identify a drainage tier of each lymph node of the two or more lymphnodes, the drainage tier including one of sentinel nodes, one or moresecondary nodes, or one or more tertiary nodes; measure radiationemission levels from the two or more lymph nodes; cause a display todisplay a user interface including: an image of a first lymph node ofthe two or more lymph nodes and first lymph node information dataincluding the radiation emission levels measured for the first lymphnode; and an image of a second lymph node of the two or more lymph nodesand second lymph node information data including the radiation emissionlevels measured for the second lymph node, wherein the image of thefirst lymph node is displayed in a first configuration based on theidentified drainage tier of the first lymph node and wherein the imageof the second lymph node is displayed in a second configurationdifferent from the first configuration based on the identified drainagetier of the second lymph node.
 30. The system according to claim 29,wherein the instructions, when executed, further cause the one or moreprocessors to: generate the user interface, the user interface includinga sampling window configured to display the identified two or more lymphnodes and a surgical tool as the surgical tool interacts with theidentified two or more lymph nodes inside the patient's body.
 31. Thesystem according to claim 29, wherein the instructions, when executed,further cause the one or more processors to: generate the userinterface, the user interface including a measured drainage windowconfigured to display a lymph node drainage pathway.
 32. The systemaccording to claim 29, wherein the instructions, when executed, furthercause the one or more processors to: generate the user interface, theuser interface including a procedure window configured to display andtrack a surgical procedure being performed.
 33. The system according toclaim 29, wherein the instructions, when executed, further cause the oneor more processors to: receive a previous 3D model of at least a portionof the patient's body from a previous procedure including previous lymphnode information data from the previous procedure; and update the 3Dmodel and the lymph node information data based on the previous 3D modeland previous lymph node information data.
 34. The system according toclaim 29, wherein the instructions, when executed, further cause the oneor more processors to: generate the user interface, the user interfaceincluding a removal window configured to display and update the firstand second lymph node information data during a surgical procedure. 35.The system according to claim 29, wherein the first and second lymphnode information data include one or more of lymph node name, patientinformation, date, or clinician information.
 36. The system according toclaim 29, wherein the instructions, when executed, further cause the oneor more processors to: generate the user interface, the user interfaceincluding a location window configured to display a portion of the 3Dmodel that corresponds with the images obtained by a laparoscopiccamera.
 37. A non-transitory computer readable storage medium, storinginstructions, which when executed by a processor, cause the processorto: generate a three-dimensional (3D) model of at least a portion of apatient's body; output a display for identifying two or more lymph nodesinside the 3D model; identify a drainage tier of each lymph node of thetwo or more lymph nodes, the drainage tier including one of sentinelnodes, one or more secondary nodes, or one or more tertiary nodes;receive measured radiation emission levels corresponding to the two ormore lymph nodes; generate a user interface including: an image of afirst lymph node of the two or more lymph nodes and first lymph nodeinformation data including the radiation emission levels measured forthe first lymph node; and an image of a second lymph node of the two ormore lymph nodes and second lymph node information data including theradiation emission levels measured for the second lymph node, whereinthe image of the first lymph node is displayed in a first configurationbased on the identified drainage tier of the first lymph node andwherein the image of the second lymph node is displayed in a secondconfiguration different from the first configuration based on theidentified drainage tier of the second lymph node.
 38. Thenon-transitory computer readable storage medium according to claim 37,wherein the instructions, when executed, further cause the processor to:generate the user interface, the user interface including a measureddrainage window configured to display a lymph node drainage pathway. 39.The non-transitory computer readable storage medium according to claim37, wherein the instructions, when executed, further cause the processorto: generate the user interface, the user interface including aprocedure window configured to display and track a surgical procedurebeing performed.
 40. The non-transitory computer readable storage mediumaccording to claim 37, wherein the instructions, when executed, furthercause the processor to: receive a previous 3D model of at least aportion of the patient's body from a previous procedure includingprevious lymph node information data from the previous procedure; andupdate the 3D model and the lymph node information data based on theprevious 3D model and previous lymph node information data.